Navigation Links
Circadin is Approved in the EU for Treatment of Primary Insomnia in Patients Aged 55 or Over for up to 3 Months
Date:7/5/2010

TEL AVIV, Israel, July 5, 2010 /PRNewswire/ -- Neurim Pharmaceuticals (http://www.Neurim.com) confirmed today that the European Commission (EC) has approved a change in treatment duration with Circadin from 3 to 13 weeks (3 months). Circadin is indicated for the treatment of primary insomnia in patients who are aged 55 or over.

The approval was based primarily on data obtained in the latest SOUNDER-SLEEP Phase IV clinical study, indicating that Circadin was safe and more effective than placebo for at least 3 months. Circadin is now the only sleep medication to be approved for up to 3 months.

The latest study was a large randomized clinical trial that analyzed more than 600 patients, over 400 of whom where on Circadin treatment for 6 months. The study demonstrated improvements in sleep latency, quality of sleep and morning alertness, with no withdrawal symptoms and rebound insomnia. The safety and efficacy data provided in the study support the proposed changes in treatment duration. In particular, the analysis of data from the new study showed that the benefit observed after 3 weeks is maintained for at least 3 months. Moreover, at 3 months, about an extra 10% of responders were seen in the Circadin treated group.

Circadin (http://www.Circadin.com) is an innovative sleep medication that has been approved by the European Medicines Agency (EMA), the Australian Therapeutic Goods Administration (TGA), the Swiss Agency for Therapeutic Products (SwissMedic) and the Israeli Ministry of Health (MOH) for the short-term treatment of primary insomnia, characterized by poor quality of sleep in patients who are aged 55 and over. The approval is based on clinical studies demonstrating positive effects on sleep quality, sleep induction, and most importantly next day alertness and functioning.

"We are pleased that the EMA recognized the importance of this therapeutic profile and recommended approval of the change in the posology of Circadin from 3 weeks to 3 months of treatment," said Professor Nava Zisapel, CSO of Neurim Pharmaceuticals, adding, "Importantly, Circadin's efficacy was maintained for at least 3 months and safety was maintained over the entire six months of treatment."

Dr. Tali Nir, VP Clinical and Regulatory Affairs of Neurim Pharmaceuticals explained that in the case of some hypnotics, concerns of safety and potential dependence issues have led to restrictions in the permitted treatment duration to ultra short periods for 2 to 4 weeks. Adding, "With Circadin there are no safety concerns and no concerns regarding withdrawal or rebound effects, as demonstrated in the study, which would limit the recommendation to treat for the full 3 month short term treatment period."

About Circadin

Circadin (http://www.Circadin.com) is the first and only IP-protected prolonged-release melatonin to be approved as an ethical drug by health authorities. Administration of Circadin to patients with primary insomnia improves sleep quality and morning alertness and facilitates sleep onset in patients aged 55 or over. Now it is also the first insomnia treatment approved for up to 13 weeks. Currently Circadin is commercialized in Europe by H.Lundbeck A/S and Nycomed, in Australia by Sigma, in Thailand by DKSH and in Israel by Teva. Circadin is undergoing registration in US, Asia and Latin American markets.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals (http://www.Neurim.com) is headquartered in Israel with offices in Switzerland and the UK. The company was founded in 1991 and is focused on drug discovery and development of treatments for age-related disorders, primarily in the central nervous system (CNS).

    For More information:
    Eran Schenker, MD
    Neurim Pharmaceuticals Ltd.
    Tel: +972-3-7684914 Cell: +972-52-6689944
    EranS@Neurim.com


'/>"/>
SOURCE Neurim Pharmaceuticals LTD
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cysview(TM) (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer
2. Hisamitsu Pharmaceutical Announces Two New FDA Approved Over-The-Counter Pain Relief Patches
3. FDA Approved VIMOVO(TM) for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers
4. Schwarz Pharma Pays $22 Million to Settle False Claims Allegations Concerning Reimbursement for Unapproved Drugs
5. Biostar Pharmaceuticals Approved for Listing on NASDAQ Global Market
6. Once-Daily MIRAPEX ER Now Approved by FDA for Both Early and Advanced Parkinsons Disease
7. PARI Pharmas Altera Delivers Gileads Cayston, Approved by the U.S. FDA for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients With Pseudomonas aeruginosa
8. United States Seizes Unapproved Ozone Generators
9. Now Approved: Fujifilms FDR AcSelerate Direct Digital DR System
10. Ampyra is First Symptom Management Drug Developed Specifically to Treat MS, the First Oral MS Therapy Approved for MS, and the First New FDA Approved Therapy to Come Through the MS Pipeline Since 2004
11. Majority of Surveyed Pharmacy Directors Expect To Cover Pfizers Tanezumab If It Is Approved for the Treatment of Chronic Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/7/2017)... 2017   Provista, a proven leader in ... in purchasing power, today announced a new resource area ... Newsroom is the online home for case studies, ... bios, news releases, slideshows and events. ... of resources at their fingertips, viewers can also watch ...
(Date:10/4/2017)... 4, 2017 OBP Medical , ... medical devices, today announced regulatory approval from ... (or Agência Nacional de Vigilância Sanitária (ANVISA)) to ... surgical retractor with integrated LED light source and ... and exposure of a tissue pocket or cavity ...
(Date:10/2/2017)... Halo Labs announces the European launch of their new low volume, ... 2017 in Cambridge, U.K on October 4th. ... samples with unprecedented speed and sensitivity while using far less sample ... ... system ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, ... ... School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, ... professionals on guideline updates for the primary prevention of cardiovascular diseases during ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... 2017 , ... The company has developed a suite of ... authorities worldwide. From Children’s to Adults 50+, every formula has been developed by ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, Preservative ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... Mohebi Hair Restoration, has recently contributed a medical article to the newly revamped ... cosmetictown.com. Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular ...
Breaking Medicine News(10 mins):